Trial Outcomes & Findings for An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread (NCT NCT02737475)
NCT ID: NCT02737475
Last Updated: 2022-01-25
Results Overview
The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
166 participants
Primary outcome timeframe
From first dose to 28 days after first dose
Results posted on
2022-01-25
Participant Flow
165 participants were randomized and treated in Parts 1-8. 1 Participant was randomized and treated in Part 9 Cohort 1. Parts 2B, 2D, 2E, 3B, 3C, and Part 9 Cohort 2 did not enroll any participants.
Participant milestones
| Measure |
Escalation Part 1: BMS 20 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 40 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 80 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
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Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
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Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
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Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
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Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
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Overall Study
STARTED
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12
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8
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8
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10
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7
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8
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18
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12
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6
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7
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1
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6
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9
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2
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2
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2
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2
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1
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Overall Study
COMPLETED
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3
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8
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0
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
| Measure |
Escalation Part 1: BMS 20 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 80 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
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Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
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Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
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Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
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Overall Study
Other reasons
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1
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1
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Overall Study
Death
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1
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1
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0
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0
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1
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Overall Study
Participant withdrew consent
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0
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0
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0
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0
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0
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2
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0
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0
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0
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0
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1
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2
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1
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0
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2
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0
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0
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0
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0
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0
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0
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Overall Study
Lost to Follow-up
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0
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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Overall Study
Disease Progression
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0
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0
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0
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0
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0
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0
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0
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0
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0
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1
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Baseline Characteristics
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986178 by Itself or in Combination With Nivolumab and/or Ipilimumab in Participants With Solid Cancers That Are Advanced or Have Spread
Baseline characteristics by cohort
| Measure |
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
8 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=40 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=26 Participants
|
100 Participants
n=12 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=40 Participants
|
7 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=600 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
66 Participants
n=12 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
8 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=600 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=26 Participants
|
67 Participants
n=12 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
17 Participants
n=135 Participants
|
4 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=40 Participants
|
9 Participants
n=40 Participants
|
2 Participants
n=41 Participants
|
1 Participants
n=600 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
99 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
1 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
6 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
4 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
6 Participants
n=135 Participants
|
5 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
1 Participants
n=15 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=40 Participants
|
1 Participants
n=41 Participants
|
2 Participants
n=600 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=26 Participants
|
89 Participants
n=12 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
12 Participants
n=135 Participants
|
7 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
6 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=40 Participants
|
6 Participants
n=40 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
71 Participants
n=12 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
1 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
4 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
4 Participants
n=12 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
18 Participants
n=135 Participants
|
11 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
7 Participants
n=667 Participants
|
1 Participants
n=15 Participants
|
5 Participants
n=40 Participants
|
8 Participants
n=40 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=600 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=26 Participants
|
155 Participants
n=12 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
0 Participants
n=12 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=600 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=26 Participants
|
2 Participants
n=12 Participants
|
PRIMARY outcome
Timeframe: From first dose to 28 days after first dosePopulation: All treated participants (Parts 1-9)
The number of participants experiencing dose-limiting toxicities (DLTs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. DLTs are defined based on the incidence, severity, and duration of adverse events (AEs) for which no clear alternative cause is identified. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days after last dose (up to approximately 2.5 years)Population: All treated participants (Parts 1-9)
The number of participants experiencing adverse events (AEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Adverse Events (AEs)
|
4 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
12 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
10 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
1 Participants
|
6 Participants
|
18 Participants
|
6 Participants
|
9 Participants
|
4 Participants
|
4 Participants
|
12 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days after last dose (up to approximately 2.5 years)Population: All treated participants (Parts 1-9)
The number of participants experiencing serious adverse events (SAEs) to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. A SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and/or is an important medical event.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Serious Adverse Events (SAEs)
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days after last dose (up to approximately 2.5 years)Population: All treated participants (Parts 1-9)
The number of participants experiencing adverse events (AEs) leading to discontinuation of study drug to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose to study completion (up to approximately 4 years 5 months)Population: All treated participants (Parts 1-9)
The number of deaths in each arm to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participant Deaths
|
3 Participants
|
4 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
11 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
9 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
2 Participants
|
16 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
11 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From baseline to 100 days after last dose (up to approximately 2.5 years)Population: All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9)
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
PLATELET COUNT GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
LEUKOCYTES GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
HEMOGLOBIN GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
PLATELET COUNT GRADE 1
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
PLATELET COUNT GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
LEUKOCYTES GRADE 1
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
LEUKOCYTES GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
LEUKOCYTES GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
ABSOLUTE NEUTROPHIL COUNT DRV. GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
HEMOGLOBIN GRADE 1
|
4 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (Hematology)
HEMOGLOBIN GRADE 2
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to 100 days after last dose (up to approximately 2.5 years)Population: All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9)
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ALANINE AMINOTRANSFERASE GRADE 1
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ALKALINE PHOSPHATASE GRADE 1
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ALKALINE PHOSPHATASE GRADE 2
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ALKALINE PHOSPHATASE GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ASPARTATE AMINOTRANSFERASE GRADE 1
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
10 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ASPARTATE AMINOTRANSFERASE GRADE 2
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ASPARTATE AMINOTRANSFERASE GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ASPARTATE AMINOTRANSFERASE GRADE 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ALANINE AMINOTRANSFERASE GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ALANINE AMINOTRANSFERASE GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
ALANINE AMINOTRANSFERASE GRADE 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
BILIRUBIN, TOTAL GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
BILIRUBIN, TOTAL GRADE 2
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
BILIRUBIN, TOTAL GRADE 3
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
BILIRUBIN, TOTAL GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
CREATININE GRADE 1
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
CREATININE GRADE 2
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (LIVER AND KIDNEY FUNCTION)
CREATININE GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From baseline to 100 days after last dose (up to approximately 2.5 years)Population: All treated participants with on-treatment laboratory results and CTC grade criteria available (Parts 1-9)
The number of participants with clinical laboratory test abnormalities to assess the overall safety and tolerability of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab in participants with advanced solid tumors. Results will be categorized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life Threatening Grade 5 = Death Related to AE Baseline is defined as the last non-missing measurement prior to the first dosing date and time
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
LIPASE, TOTAL GRADE 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
LIPASE, TOTAL GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
LIPASE, TOTAL GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
SODIUM, SERUM GRADE 1
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
SODIUM, SERUM GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
LIPASE, TOTAL GRADE 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
SODIUM, SERUM GRADE 3
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
POTASSIUM, SERUM GRADE 1
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
8 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
POTASSIUM, SERUM GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
POTASSIUM, SERUM GRADE 3
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
POTASSIUM, SERUM GRADE 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
CALCIUM, TOTAL GRADE 1
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
9 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
CALCIUM, TOTAL GRADE 2
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
CALCIUM, TOTAL GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
MAGNESIUM, SERUM GRADE 1
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
MAGNESIUM, SERUM GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
MAGNESIUM, SERUM GRADE 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
GLUCOSE, FASTING SERUM GRADE 1
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
—
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
GLUCOSE, FASTING SERUM GRADE 2
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
GLUCOSE, FASTING SERUM GRADE 3
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
ALBUMIN GRADE 1
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
ALBUMIN GRADE 2
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
ALBUMIN GRADE 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
AMYLASE, TOTAL GRADE 1
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
AMYLASE, TOTAL GRADE 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
AMYLASE, TOTAL GRADE 3
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Clinical Laboratory Test Abnormalities (OTHER CHEMISTRY TESTING )
AMYLASE, TOTAL GRADE 4
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SECONDARY outcome
Timeframe: From baseline up to approximately 2.5 yearsPopulation: Response Evaluable Participants (Parts 1-9)
The total number of participants whose best overall response (BOR) is either a complete response (CR) or partial response (PR) based on assessment of tumor response using RECIST v1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Overall Response (OR) = CR + PR Baseline is defined as the last non-missing measurement prior to the first dosing date and time.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=9 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=5 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
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Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
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Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
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Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
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Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
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Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
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Objective Response Rate (ORR)
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0 Participants
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0 Participants
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0 Participants
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0 Participants
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2 Participants
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1 Participants
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1 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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0 Participants
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0 Participants
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0 Participants
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1 Participants
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2 Participants
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0 Participants
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NA Participants
BOR was not evaluable for the patient due to death prior to any tumor assessment
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SECONDARY outcome
Timeframe: From baseline up to approximately 2.5 yearsPopulation: The number of responders within each tumor type was not sufficient for analysis. (Parts 1-8)
The time between the date of first response and the subsequent date of disease progression or death (death after re-treatment will not be considered), whichever occurs first in participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Baseline is defined as the last non-missing measurement prior to the first dosing date and time. Due to high percentage of censored response, median estimate may be misleading
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 160 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 320 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=2 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=1 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=1 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=1 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=1 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
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Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
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Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=1 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
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Escalation Part 1: BMS 20 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 40 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
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Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
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Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
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Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
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Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
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Duration of Response (DOR)
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NA Weeks
KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.
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17.14 Weeks
KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.
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NA Weeks
KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.
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NA Weeks
KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.
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64.14 Weeks
KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.
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—
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NA Weeks
KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.
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NA Weeks
KM methodology requires having more than 50% of events to estimate the median and/or upper/lower limits.
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SECONDARY outcome
Timeframe: 24 weeks after first dosePopulation: All treated Participants (Parts 1-8)
The percentage of treated participants remaining progression free and surviving at 24 weeks since the first dosing date.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
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Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
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Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
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Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival (PFS) Rate at 24 Weeks
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
25.0 Percentage of participants
Interval 0.9 to 66.5
|
25.0 Percentage of participants
Interval 0.9 to 66.5
|
17.9 Percentage of participants
Interval 0.8 to 53.8
|
42.9 Percentage of participants
Interval 9.8 to 73.4
|
16.7 Percentage of participants
Interval 2.7 to 41.3
|
28.6 Percentage of participants
Interval 4.1 to 61.2
|
37.5 Percentage of participants
Interval 8.7 to 67.4
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
11.1 Percentage of participants
Interval 0.6 to 38.8
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
28.6 Percentage of participants
Interval 4.1 to 61.2
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
NA Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
40.0 Percentage of participants
Interval 5.2 to 75.3
|
22.2 Percentage of participants
Interval 6.9 to 42.9
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
33.3 Percentage of participants
Interval 7.8 to 62.3
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).)
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
9.2 Percentage of participants
Interval 0.5 to 33.5
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
0.0 Percentage of participants
The estimate (or confidence of estimate) is N.A because no observations were available for calculation of estimate (or confidence of estimate).
|
50.0 Percentage of participants
Interval 0.6 to 91.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Serum Concentration
CYCLE 1 DAY 1
|
19254 NG/ML
Geometric Coefficient of Variation 18
|
36143 NG/ML
Geometric Coefficient of Variation 14
|
68774 NG/ML
Geometric Coefficient of Variation 20
|
9424 NG/ML
Geometric Coefficient of Variation 133
|
11699 NG/ML
Geometric Coefficient of Variation 13
|
19547 NG/ML
Geometric Coefficient of Variation 39
|
39182 NG/ML
Geometric Coefficient of Variation 37
|
76445 NG/ML
Geometric Coefficient of Variation 22
|
7860 NG/ML
Geometric Coefficient of Variation 35
|
9345 NG/ML
Geometric Coefficient of Variation 20
|
17979 NG/ML
Geometric Coefficient of Variation 31
|
11139 NG/ML
Geometric Coefficient of Variation 19
|
55790 NG/ML
Geometric Coefficient of Variation 107
|
—
|
65472 NG/ML
Geometric Coefficient of Variation 27
|
17586 NG/ML
Geometric Coefficient of Variation 25
|
14267 NG/ML
Geometric Coefficient of Variation 37
|
15424 NG/ML
Geometric Coefficient of Variation 173
|
4964 NG/ML
Geometric Coefficient of Variation 11
|
11245 NG/ML
Geometric Coefficient of Variation 34
|
19012 NG/ML
Geometric Coefficient of Variation 22
|
21399 NG/ML
Geometric Coefficient of Variation 12
|
3270 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
11300 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
|
Cmax: Maximum Observed Serum Concentration
CYCLE 4 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
8960 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
10273 NG/ML
Geometric Coefficient of Variation 12
|
20900 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
11261 NG/ML
Geometric Coefficient of Variation 21
|
69922 NG/ML
Geometric Coefficient of Variation 36
|
—
|
117839 NG/ML
Geometric Coefficient of Variation 15
|
—
|
—
|
14143 NG/ML
Geometric Coefficient of Variation 47
|
—
|
—
|
—
|
31800 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
|
Cmax: Maximum Observed Serum Concentration
CYCLE 5 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16912 NG/ML
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax: Maximum Observed Serum Concentration
CYCLE 9 DAY 1
|
23200 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
61500 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
17392 NG/ML
Geometric Coefficient of Variation 19
|
23097 NG/ML
Geometric Coefficient of Variation 66
|
72991 NG/ML
Geometric Coefficient of Variation 12
|
207853 NG/ML
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
30922 NG/ML
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The time of maximum observed serum concentration was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time of Maximum Observed Serum Concentration
CYCLE 1 DAY 1
|
4.58 Hours
Interval 0.5 to 24.0
|
2.30 Hours
Interval 0.567 to 4.02
|
0.558 Hours
Interval 0.467 to 4.08
|
0.467 Hours
Interval 0.467 to 4.0
|
2.34 Hours
Interval 0.467 to 4.08
|
0.517 Hours
Interval 0.467 to 4.5
|
0.650 Hours
Interval 0.517 to 4.1
|
0.792 Hours
Interval 0.45 to 4.5
|
0.667 Hours
Interval 0.633 to 4.08
|
4.00 Hours
Interval 0.467 to 4.13
|
4.00 Hours
Interval 0.467 to 4.43
|
0.583 Hours
Interval 0.467 to 4.08
|
2.55 Hours
Interval 0.467 to 24.1
|
—
|
4.13 Hours
Interval 0.467 to 4.62
|
4.09 Hours
Interval 0.467 to 4.82
|
4.00 Hours
Interval 0.517 to 23.0
|
0.475 Hours
Interval 0.467 to 4.75
|
0.675 Hours
Interval 0.467 to 4.52
|
0.575 Hours
Interval 0.467 to 0.933
|
0.550 Hours
Interval 0.5 to 24.0
|
2.30 Hours
Interval 0.467 to 4.55
|
0.533 Hours
Interval 0.533 to 0.533
|
4.83 Hours
Interval 4.83 to 4.83
|
—
|
—
|
—
|
|
Tmax: Time of Maximum Observed Serum Concentration
CYCLE 4 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.583 Hours
Interval 0.583 to 0.583
|
4.00 Hours
Interval 0.617 to 24.0
|
0.583 Hours
Interval 0.583 to 0.583
|
0.517 Hours
Interval 0.5 to 0.583
|
4.00 Hours
Interval 0.467 to 24.9
|
—
|
2.58 Hours
Interval 0.467 to 4.68
|
—
|
—
|
0.467 Hours
Interval 0.0 to 4.0
|
—
|
—
|
—
|
4.03 Hours
Interval 4.03 to 4.03
|
—
|
—
|
—
|
—
|
—
|
|
Tmax: Time of Maximum Observed Serum Concentration
CYCLE 5 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.550 Hours
Interval 0.517 to 0.583
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax: Time of Maximum Observed Serum Concentration
CYCLE 9 DAY 1
|
0.467 Hours
Interval 0.467 to 0.467
|
22.7 Hours
Interval 22.7 to 22.7
|
—
|
—
|
0.567 Hours
Interval 0.467 to 4.0
|
4.47 Hours
Interval 4.02 to 4.5
|
2.38 Hours
Interval 0.633 to 4.12
|
4.05 Hours
Interval 3.98 to 23.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
3.94 Hours
Interval 0.5 to 4.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The area under the serum concentration-time curve from time 0 to time t was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
CYCLE 1 DAY 1
|
1825502 H*NG/ML
Geometric Coefficient of Variation 61
|
5024906 H*NG/ML
Geometric Coefficient of Variation 32
|
9981469 H*NG/ML
Geometric Coefficient of Variation 9
|
609426 H*NG/ML
Geometric Coefficient of Variation 62
|
1495494 H*NG/ML
Geometric Coefficient of Variation 27
|
2324225 H*NG/ML
Geometric Coefficient of Variation 24
|
5458640 H*NG/ML
Geometric Coefficient of Variation 47
|
8694104 H*NG/ML
Geometric Coefficient of Variation 46
|
1047354 H*NG/ML
Geometric Coefficient of Variation 49
|
1197507 H*NG/ML
Geometric Coefficient of Variation 43
|
2774058 H*NG/ML
Geometric Coefficient of Variation 56
|
1251698 H*NG/ML
Geometric Coefficient of Variation 49
|
7257441 H*NG/ML
Geometric Coefficient of Variation 34
|
—
|
10580541 H*NG/ML
Geometric Coefficient of Variation 41
|
2351794 H*NG/ML
Geometric Coefficient of Variation 29
|
1653102 H*NG/ML
Geometric Coefficient of Variation 22
|
864500 H*NG/ML
Geometric Coefficient of Variation 57
|
577541 H*NG/ML
Geometric Coefficient of Variation 31
|
1678196 H*NG/ML
Geometric Coefficient of Variation 23
|
2000522 H*NG/ML
Geometric Coefficient of Variation 43
|
3216650 H*NG/ML
Geometric Coefficient of Variation 21
|
390424 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
2399055 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
|
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
CYCLE 4 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
773957 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
2210404 H*NG/ML
Geometric Coefficient of Variation 21
|
2400433 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
1837861 H*NG/ML
Geometric Coefficient of Variation 10
|
10729551 H*NG/ML
Geometric Coefficient of Variation 38
|
—
|
23851864 H*NG/ML
Geometric Coefficient of Variation 14
|
—
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—
|
504998 H*NG/ML
Geometric Coefficient of Variation 91
|
—
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—
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—
|
2699238 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
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—
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—
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—
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—
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|
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
CYCLE 5 DAY 1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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2520673 H*NG/ML
Geometric Coefficient of Variation 50
|
—
|
—
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—
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—
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—
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—
|
|
AUC(0-t): Area Under the Serum Concentration-time Curve From Time 0 to Time t
CYCLE 9 DAY 1
|
3952990 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
13024914 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
2971409 H*NG/ML
Geometric Coefficient of Variation 53
|
1247687 H*NG/ML
Geometric Coefficient of Variation 118
|
16483279 H*NG/ML
Geometric Coefficient of Variation 37
|
28499982 H*NG/ML
Geometric Coefficient of Variation 78
|
—
|
—
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—
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—
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—
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—
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—
|
4537054 H*NG/ML
Geometric Coefficient of Variation 42
|
—
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The area under the serum concentration-time curve in 1 dosing interval was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
CYCLE 1 DAY 1
|
3142196 H*NG/ML
Geometric Coefficient of Variation 21
|
5854143 H*NG/ML
Geometric Coefficient of Variation 19
|
9981469 H*NG/ML
Geometric Coefficient of Variation 9
|
663257 H*NG/ML
Geometric Coefficient of Variation 60
|
1515139 H*NG/ML
Geometric Coefficient of Variation 24
|
2551115 H*NG/ML
Geometric Coefficient of Variation 24
|
5458640 H*NG/ML
Geometric Coefficient of Variation 47
|
11483961 H*NG/ML
Geometric Coefficient of Variation 26
|
1383126 H*NG/ML
Geometric Coefficient of Variation 28
|
1521223 H*NG/ML
Geometric Coefficient of Variation 31
|
3133192 H*NG/ML
Geometric Coefficient of Variation 49
|
1568004 H*NG/ML
Geometric Coefficient of Variation 33
|
7464248 H*NG/ML
Geometric Coefficient of Variation 32
|
—
|
11966698 H*NG/ML
Geometric Coefficient of Variation 34
|
2602049 H*NG/ML
Geometric Coefficient of Variation 23
|
1705864 H*NG/ML
Geometric Coefficient of Variation 10
|
1410042 H*NG/ML
Geometric Coefficient of Variation 23
|
577541 H*NG/ML
Geometric Coefficient of Variation 31
|
1599886 H*NG/ML
Geometric Coefficient of Variation 29
|
2734577 H*NG/ML
Geometric Coefficient of Variation 31
|
3500606 H*NG/ML
Geometric Coefficient of Variation 28
|
447709 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
2812249 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
|
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
CYCLE 4 DAY 1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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2210404 H*NG/ML
Geometric Coefficient of Variation 21
|
—
|
1837861 H*NG/ML
Geometric Coefficient of Variation 10
|
12666237 H*NG/ML
Geometric Coefficient of Variation 39
|
—
|
27936423 H*NG/ML
Geometric Coefficient of Variation 8
|
—
|
—
|
3590883 H*NG/ML
Geometric Coefficient of Variation 12
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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|
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
CYCLE 5 DAY 1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
3335668 H*NG/ML
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC(TAU): Area Under the Serum Concentration-time Curve in 1 Dosing Interval
CYCLE 9 DAY 1
|
3952990 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
13024914 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
3345948 H*NG/ML
Geometric Coefficient of Variation 40
|
3307867 H*NG/ML
Geometric Coefficient of Variation 83
|
16483279 H*NG/ML
Geometric Coefficient of Variation 37
|
50254284 H*NG/ML
Geometric Coefficient of Variation 42
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
6176469 H*NG/ML
Geometric Coefficient of Variation 17
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The observed serum concentration at the end of a dosing interval when intensive samples are collected was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
CYCLE 1 DAY 1
|
5354 NG/ML
Geometric Coefficient of Variation 31
|
10852 NG/ML
Geometric Coefficient of Variation 44
|
16514 NG/ML
Geometric Coefficient of Variation 4
|
756 NG/ML
Geometric Coefficient of Variation 108
|
1904 NG/ML
Geometric Coefficient of Variation 37
|
3598 NG/ML
Geometric Coefficient of Variation 37
|
10413 NG/ML
Geometric Coefficient of Variation 51
|
18596 NG/ML
Geometric Coefficient of Variation 41
|
885 NG/ML
Geometric Coefficient of Variation 56
|
604 NG/ML
Geometric Coefficient of Variation 67
|
2335 NG/ML
Geometric Coefficient of Variation 87
|
790 NG/ML
Geometric Coefficient of Variation 88
|
3059 NG/ML
Geometric Coefficient of Variation 93
|
—
|
7739 NG/ML
Geometric Coefficient of Variation 72
|
3928 NG/ML
Geometric Coefficient of Variation 33
|
1535 NG/ML
Geometric Coefficient of Variation 35
|
1533 NG/ML
Geometric Coefficient of Variation 54
|
657 NG/ML
Geometric Coefficient of Variation 62
|
2577 NG/ML
Geometric Coefficient of Variation 30
|
544 NG/ML
Geometric Coefficient of Variation 76
|
1725 NG/ML
Geometric Coefficient of Variation 76
|
0.004 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
42.9 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
|
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
CYCLE 4 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2527 NG/ML
Geometric Coefficient of Variation 68
|
—
|
1262 NG/ML
Geometric Coefficient of Variation 10
|
7729 NG/ML
Geometric Coefficient of Variation 49
|
—
|
32982 NG/ML
Geometric Coefficient of Variation 33
|
—
|
—
|
6906 NG/ML
Geometric Coefficient of Variation 20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
CYCLE 5 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1412 NG/ML
Geometric Coefficient of Variation 78
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctau: Observed Serum Concentration at the End of a Dosing Interval When Intensive Samples Are Collected
CYCLE 9 DAY 1
|
6470 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
33600 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
5510 NG/ML
Geometric Coefficient of Variation 68
|
5686 NG/ML
Geometric Coefficient of Variation 78
|
34303 NG/ML
Geometric Coefficient of Variation 25
|
131520 NG/ML
Geometric Coefficient of Variation 70
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13400 NG/ML
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The total body clearance was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
CLT: Total Body Clearance
CYCLE 4 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.018 L/H
Geometric Coefficient of Variation 24
|
—
|
0.022 L/H
Geometric Coefficient of Variation 10
|
0.013 L/H
Geometric Coefficient of Variation 44
|
—
|
0.011 L/H
Geometric Coefficient of Variation 8
|
—
|
—
|
0.011 L/H
Geometric Coefficient of Variation 13
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
CLT: Total Body Clearance
CYCLE 5 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.024 L/H
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
—
|
—
|
|
CLT: Total Body Clearance
CYCLE 9 DAY 1
|
0.020 L/H
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
0.012 L/H
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
0.012 L/H
Geometric Coefficient of Variation 38
|
0.024 L/H
Geometric Coefficient of Variation 83
|
0.010 L/H
Geometric Coefficient of Variation 37
|
0.006 L/H
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.013 L/H
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The average concentration over a dosing interval (AUC(TAU)/tau) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau)
CYCLE 4 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4379 NG/ML
Geometric Coefficient of Variation 21
|
—
|
3715 NG/ML
Geometric Coefficient of Variation 10
|
25131 NG/ML
Geometric Coefficient of Variation 39
|
—
|
55386 NG/ML
Geometric Coefficient of Variation 8
|
—
|
—
|
10739 NG/ML
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
|
Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau)
CYCLE 5 DAY 1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
4964 NG/ML
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Css-avg: Average Concentration Over a Dosing Interval (AUC(TAU)/Tau)
CYCLE 9 DAY 1
|
11826 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
45155 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
9746 NG/ML
Geometric Coefficient of Variation 42
|
9903 NG/ML
Geometric Coefficient of Variation 83
|
45878 NG/ML
Geometric Coefficient of Variation 27
|
148579 NG/ML
Geometric Coefficient of Variation 42
|
—
|
—
|
—
|
—
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—
|
—
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—
|
19538 NG/ML
Geometric Coefficient of Variation 19
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax)
CYCLE 4 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0.793 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
1.05 NG/ML
Geometric Coefficient of Variation 21
|
1.67 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
1.03 NG/ML
Geometric Coefficient of Variation 15
|
1.40 NG/ML
Geometric Coefficient of Variation 18
|
—
|
1.52 NG/ML
Geometric Coefficient of Variation 18
|
—
|
—
|
1.21 NG/ML
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
1.32 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
|
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax)
CYCLE 5 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.02 NG/ML
Geometric Coefficient of Variation 5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Cmax)
CYCLE 9 DAY 1
|
1.45 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
1.89 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
1.40 NG/ML
Geometric Coefficient of Variation 22
|
1.29 NG/ML
Geometric Coefficient of Variation 66
|
1.83 NG/ML
Geometric Coefficient of Variation 14
|
2.56 NG/ML
Geometric Coefficient of Variation 29
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.66 NG/ML
Geometric Coefficient of Variation 32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC)
CYCLE 4 DAY 1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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1.28 H*NG/ML
Geometric Coefficient of Variation 7
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—
|
1.37 H*NG/ML
Geometric Coefficient of Variation 12
|
1.56 H*NG/ML
Geometric Coefficient of Variation 19
|
—
|
1.77 H*NG/ML
Geometric Coefficient of Variation 27
|
—
|
—
|
2.13 H*NG/ML
Geometric Coefficient of Variation 116
|
—
|
—
|
—
|
0.000 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
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—
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—
|
|
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC)
CYCLE 5 DAY 1
|
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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1.21 H*NG/ML
Geometric Coefficient of Variation 34
|
—
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—
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—
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—
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—
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—
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|
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (AUC)
CYCLE 9 DAY 1
|
—
|
2.21 H*NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
1.85 H*NG/ML
Geometric Coefficient of Variation 24
|
0.748 H*NG/ML
Geometric Coefficient of Variation 141
|
2.78 H*NG/ML
Geometric Coefficient of Variation 34
|
4.40 H*NG/ML
Geometric Coefficient of Variation 87
|
—
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—
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—
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—
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—
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—
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—
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2.32 H*NG/ML
Geometric Coefficient of Variation 9
|
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—
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SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The ratio of an exposure measure at steady state to that after the first dose was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau)
CYCLE 4 DAY 1
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
1.90 NG/ML
Geometric Coefficient of Variation 73
|
—
|
2.47 NG/ML
Geometric Coefficient of Variation 57
|
1.22 NG/ML
Geometric Coefficient of Variation 16
|
—
|
1.89 NG/ML
Geometric Coefficient of Variation 29
|
—
|
—
|
2.72 NG/ML
Geometric Coefficient of Variation 116
|
—
|
—
|
—
|
0.000 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
|
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau)
CYCLE 5 DAY 1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
1.05 NG/ML
Geometric Coefficient of Variation 48
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AI: Accumulation Index. Ratio of an Exposure Measure at Steady State (Ctau)
CYCLE 9 DAY 1
|
—
|
2.33 NG/ML
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
2.40 NG/ML
Geometric Coefficient of Variation 36
|
1.22 NG/ML
Geometric Coefficient of Variation 141
|
2.61 NG/ML
Geometric Coefficient of Variation 11
|
7.55 NG/ML
Geometric Coefficient of Variation 87
|
—
|
—
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—
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—
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—
|
—
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—
|
3.49 NG/ML
Geometric Coefficient of Variation 11
|
—
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—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
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—
|
SECONDARY outcome
Timeframe: Cycle 1-9 timepoints can include (Pre-dose, 0.30, 4, 24, 72, 168, 336, 696 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
The effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax)
CYCLE 4 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
229 Hr
Standard Deviation 40
|
—
|
261 Hr
Standard Deviation 58
|
345 Hr
Standard Deviation 111
|
—
|
429 Hr
Standard Deviation 182
|
—
|
—
|
146 Hr
Standard Deviation 200
|
—
|
—
|
—
|
0.000 Hr
Standard Deviation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
|
T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax)
CYCLE 5 DAY 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
447 Hr
Standard Deviation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
—
|
|
T-HALFeff: Effective Elimination Half-life That Explains the Degree of Accumulation Observed for a Specific Exposure Measure (Exposure Measure Includes AUC(TAU), Cmax)
CYCLE 9 DAY 1
|
0.000 Hr
Standard Deviation NA
No measure of variation/dispersion for a single data value
|
331 Hr
Standard Deviation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
315 Hr
Standard Deviation 119
|
0.000 Hr
Standard Deviation 0.000
|
593 Hr
Standard Deviation 308
|
607 Hr
Standard Deviation 527
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
312 Hr
Standard Deviation 180
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-17 timepoints can include (Pre-dose, 336, 504, 672 hours post dose)Population: Pharmacokinetic participants: All participants with available serum time-concentration data from subjects who received any BMS-986178 or Nivolumab or Ipilimumab. (Parts 1-9)
Trough observed plasma concentration (this includes predose concentrations and Ctau concentrations) was measured after dosing to assess the pharmacokinetics of BMS-986178 administered alone or in combination with Nivolumab and/or Ipilimumab. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 Participants
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 Participants
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 Participants
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 Participants
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 Participants
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 Participants
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 Participants
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 Participants
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 7 DAY 1 0 h
|
10217 ng/mL
Geometric Coefficient of Variation 45.8
|
22073 ng/mL
Geometric Coefficient of Variation 60.3
|
—
|
946 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
4777 ng/mL
Geometric Coefficient of Variation 75.6
|
12527 ng/mL
Geometric Coefficient of Variation 58.8
|
32753 ng/mL
Geometric Coefficient of Variation 53.9
|
76970 ng/mL
Geometric Coefficient of Variation 33.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
11471 ng/mL
Geometric Coefficient of Variation 38.5
|
—
|
—
|
—
|
5390 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 9 DAY 1 0 h
|
6300 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
31300 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
6397 ng/mL
Geometric Coefficient of Variation 50.5
|
13536 ng/mL
Geometric Coefficient of Variation 105
|
29902 ng/mL
Geometric Coefficient of Variation 30.0
|
106710 ng/mL
Geometric Coefficient of Variation 40.9
|
—
|
—
|
—
|
579 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
12905 ng/mL
Geometric Coefficient of Variation 42.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 1 DAY 15 336 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1535 ng/mL
Geometric Coefficient of Variation 34.9
|
1912 ng/mL
Geometric Coefficient of Variation 45.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 1 DAY 29 0 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1354 ng/mL
Geometric Coefficient of Variation 65.0
|
1108 ng/mL
Geometric Coefficient of Variation 72.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 2 DAY 1 0 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1391 ng/mL
Geometric Coefficient of Variation 63.3
|
1107 ng/mL
Geometric Coefficient of Variation 84.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 2 DAY 1 336 h
|
5354 ng/mL
Geometric Coefficient of Variation 31.0
|
10852 ng/mL
Geometric Coefficient of Variation 44.3
|
16514 ng/mL
Geometric Coefficient of Variation 4.14
|
561 ng/mL
Geometric Coefficient of Variation 119
|
1995 ng/mL
Geometric Coefficient of Variation 35.1
|
4006 ng/mL
Geometric Coefficient of Variation 31.0
|
10413 ng/mL
Geometric Coefficient of Variation 51.3
|
18596 ng/mL
Geometric Coefficient of Variation 41.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4070 ng/mL
Geometric Coefficient of Variation 30.7
|
—
|
—
|
657 ng/mL
Geometric Coefficient of Variation 62.2
|
2372 ng/mL
Geometric Coefficient of Variation 38.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 2 DAY 1 504 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
456 ng/mL
Geometric Coefficient of Variation 85.5
|
591 ng/mL
Geometric Coefficient of Variation 76.7
|
2401 ng/mL
Geometric Coefficient of Variation 86.0
|
745 ng/mL
Geometric Coefficient of Variation 90.9
|
1921 ng/mL
Geometric Coefficient of Variation 103
|
1030 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
7739 ng/mL
Geometric Coefficient of Variation 72.3
|
—
|
—
|
—
|
—
|
—
|
—
|
2166 ng/mL
Geometric Coefficient of Variation 33.7
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 2 DAY 1 672 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
676 ng/mL
Geometric Coefficient of Variation 105
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 3 DAY 1 0 h
|
5903 ng/mL
Geometric Coefficient of Variation 45.5
|
16974 ng/mL
Geometric Coefficient of Variation 28.9
|
21571 ng/mL
Geometric Coefficient of Variation 15.9
|
614 ng/mL
Geometric Coefficient of Variation 122
|
1825 ng/mL
Geometric Coefficient of Variation 70.1
|
4498 ng/mL
Geometric Coefficient of Variation 45.4
|
16379 ng/mL
Geometric Coefficient of Variation 43.6
|
28282 ng/mL
Geometric Coefficient of Variation 43.2
|
323 ng/mL
Geometric Coefficient of Variation 101
|
2049 ng/mL
Geometric Coefficient of Variation 40.1
|
4894 ng/mL
Geometric Coefficient of Variation 60.7
|
689 ng/mL
Geometric Coefficient of Variation 123
|
2766 ng/mL
Geometric Coefficient of Variation 99.8
|
—
|
20410 ng/mL
Geometric Coefficient of Variation 42.5
|
5055 ng/mL
Geometric Coefficient of Variation 46.8
|
—
|
2469 ng/mL
Geometric Coefficient of Variation 64.6
|
1290 ng/mL
Geometric Coefficient of Variation 43.3
|
4244 ng/mL
Geometric Coefficient of Variation 36.2
|
1480 ng/mL
Geometric Coefficient of Variation 81.5
|
62.5 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 4 DAY 1 0 h
|
7169 ng/mL
Geometric Coefficient of Variation 37.3
|
20703 ng/mL
Geometric Coefficient of Variation 32.1
|
26090 ng/mL
Geometric Coefficient of Variation 13.0
|
358 ng/mL
Geometric Coefficient of Variation 95.8
|
2095 ng/mL
Geometric Coefficient of Variation 96.5
|
5108 ng/mL
Geometric Coefficient of Variation 71.4
|
20800 ng/mL
Geometric Coefficient of Variation 43.7
|
47108 ng/mL
Geometric Coefficient of Variation 45.2
|
1080 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
1971 ng/mL
Geometric Coefficient of Variation 51.3
|
5140 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
754 ng/mL
Geometric Coefficient of Variation 48.1
|
12649 ng/mL
Geometric Coefficient of Variation 78.3
|
—
|
32150 ng/mL
Geometric Coefficient of Variation 0.660
|
7252 ng/mL
Geometric Coefficient of Variation 43.4
|
—
|
5461 ng/mL
Geometric Coefficient of Variation 26.4
|
3420 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
4593 ng/mL
Geometric Coefficient of Variation 24.0
|
1466 ng/mL
Geometric Coefficient of Variation 72.4
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 4 DAY 29 0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1856 ng/mL
Geometric Coefficient of Variation 75.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 4 DAY 15 336 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2130 ng/mL
Geometric Coefficient of Variation 69.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 5 DAY 1 0 h
|
13491 ng/mL
Geometric Coefficient of Variation 36.0
|
13300 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
35200 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
386 ng/mL
Geometric Coefficient of Variation 84.8
|
1301 ng/mL
Geometric Coefficient of Variation 100
|
7468 ng/mL
Geometric Coefficient of Variation 55.1
|
26813 ng/mL
Geometric Coefficient of Variation 52.7
|
90700 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
9811 ng/mL
Geometric Coefficient of Variation 37.3
|
—
|
—
|
—
|
6600 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
1671 ng/mL
Geometric Coefficient of Variation 63.5
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 5 DAY 1 504 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
2527 ng/mL
Geometric Coefficient of Variation 67.6
|
—
|
1262 ng/mL
Geometric Coefficient of Variation 10.2
|
—
|
—
|
18771 ng/mL
Geometric Coefficient of Variation 45.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 6 DAY 1 0 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
604 ng/mL
Geometric Coefficient of Variation 138
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 6 DAY 1 672 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
62.5 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 10 DAY 1 0 h
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
29100 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 10 DAY 1 336 h
|
6470 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
33600 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
1190 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
8264 ng/mL
Geometric Coefficient of Variation 44.0
|
5686 ng/mL
Geometric Coefficient of Variation 78.2
|
28988 ng/mL
Geometric Coefficient of Variation 33.9
|
131520 ng/mL
Geometric Coefficient of Variation 70.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
13400 ng/mL
Geometric Coefficient of Variation 26.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctrough: Trough Observed Plasma Concentration
CYCLE 17 DAY 1 0 h
|
—
|
—
|
—
|
—
|
—
|
—
|
48500 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
16600 ng/mL
Geometric Coefficient of Variation NA
No measure of variation/dispersion for a single data value
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-6 timepoints can include (Pre-dose, 696 hours post dose)Population: All BMS 986178 Treated Participants with Baseline and at Least One Post-baseline ADA Assessment (Parts 1-9)
The number of participants with positive anti-drug antibodies (ADA) is assessed to characterize the immunogenicity of BMS-986178 administered alone or in combination with nivolumab and/or ipilimumab. ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=3 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=3 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=3 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=6 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=6 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=6 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=7 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=5 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=2 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=5 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=7 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=3 Participants
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=1 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=2 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=2 Participants
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=1 Participants
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=1 Participants
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Positive Anti-Drug Antibodies (ADA) to BMS-986178
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
4 Participants
|
—
|
2 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-6 timepoints can include (Pre-dose, 336, 696 hours post dose)Population: All BMS 986178 Treated Participants with Baseline and at Least One Post-baseline ADA Assessment (Parts 1-9)
The number of participants with positive anti-drug antibodies (ADA) is assessed to characterize the immunogenicity of Nivolumab administered with BMS-986178 ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=8 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=8 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=6 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=17 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=9 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=5 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=1 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=5 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=9 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=1 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=1 Participants
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=5 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=7 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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Frequency of Positive Anti-Drug Antibodies (ADA) to Nivolumab
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
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1 Participants
|
—
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—
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—
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0 Participants
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—
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—
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—
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0 Participants
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1 Participants
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—
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—
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—
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—
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—
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—
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—
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SECONDARY outcome
Timeframe: Cycle 1-6 timepoints can include (Pre-dose, 696 hours post dose)Population: All BMS 986178 Treated Participants with Baseline and at Least One Post-baseline ADA Assessment (Parts 1-9)
The number of participants with positive anti-drug antibodies (ADA) is assessed to characterize the immunogenicity of Ipilimumab administered with BMS-986178 ADA Positive: A participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (\>=) than baseline positive titer) at any time after initiation of treatment.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=7 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=7 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=6 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=6 Participants
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=6 Participants
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=1 Participants
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=5 Participants
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=9 Participants
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=4 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=5 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Frequency of Positive Anti-Drug Antibodies (ADA) to Ipilimumab.
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1-6 timepoints can include (Pre-dose, 24, 168, 336, 672, 1848 hours post dose)Population: All treated participants with Pharmacodynamic biomarker assessments (Part 8)
The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8. A threshold of 80% receptor occupancy following treatment was applied.
Outcome measures
| Measure |
Escalation Part 1: BMS 80 mg Q2W
n=2 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=2 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Escalation Part 1: BMS 20 mg Q2W
n=2 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=2 Participants
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8
Peripheral OX40 receptor occupancy (CD4+ T cells)
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
|
—
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—
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—
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1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
The Number of Participants Showing a Change in Soluble OX40 and Peripheral OX40 Receptor Occupancy Pharmacodynamic Biomarkers in Part 8
Peripheral OX40 receptor occupancy (Tregs)
|
1 Participants
|
0 Participants
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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1 Participants
|
1 Participants
|
—
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—
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—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Screening, cycle 1-2 timepoints can include (Pre-dose, 336, 1848 hours post dose)Population: Tumor pharmacodynamic readouts not possible due to only 1 matched pair
Tumor pharmacodynamics of BMS-986178 in combination with nivolumab or nivolumab monotherapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1-6 timepoints can include (Pre-dose, 24, 168, 336, 672, 1848 hours post dose)Population: All treated participants with available biomarker data (Part 9)
The number of participants with Sustained T Cell Expansion with DPV-001 in Combination with Nivolumab or Nivolumab Monotherapy was assessed to show a change in pharmacodynamics biomarkers
Outcome measures
Outcome data not reported
Adverse Events
Escalation Part 1: BMS 20 mg Q2W
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Escalation Part 1: BMS 40 mg Q2W
Serious events: 4 serious events
Other events: 4 other events
Deaths: 4 deaths
Escalation Part 1: BMS 80 mg Q2W
Serious events: 2 serious events
Other events: 4 other events
Deaths: 3 deaths
Escalation Part 1: BMS 160 mg Q2W
Serious events: 3 serious events
Other events: 3 other events
Deaths: 4 deaths
Escalation Part 1: BMS 320 mg Q2W
Serious events: 3 serious events
Other events: 4 other events
Deaths: 4 deaths
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
Serious events: 3 serious events
Other events: 7 other events
Deaths: 3 deaths
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
Serious events: 6 serious events
Other events: 8 other events
Deaths: 7 deaths
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
Serious events: 7 serious events
Other events: 12 other events
Deaths: 11 deaths
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
Serious events: 4 serious events
Other events: 6 other events
Deaths: 6 deaths
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
Serious events: 5 serious events
Other events: 8 other events
Deaths: 6 deaths
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
Serious events: 6 serious events
Other events: 10 other events
Deaths: 9 deaths
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
Serious events: 6 serious events
Other events: 7 other events
Deaths: 7 deaths
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
Serious events: 5 serious events
Other events: 8 other events
Deaths: 8 deaths
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
Serious events: 11 serious events
Other events: 18 other events
Deaths: 16 deaths
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
Serious events: 7 serious events
Other events: 11 other events
Deaths: 11 deaths
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Serious events: 4 serious events
Other events: 5 other events
Deaths: 3 deaths
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
Serious events: 6 serious events
Other events: 6 other events
Deaths: 5 deaths
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 4 deaths
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
Serious events: 1 serious events
Other events: 2 other events
Deaths: 2 deaths
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Escalation Part 1: BMS 20 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 80 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 participants at risk
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 participants at risk
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 participants at risk
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 participants at risk
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 participants at risk
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 participants at risk
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 participants at risk
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 participants at risk
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 participants at risk
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 participants at risk
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 participants at risk
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 participants at risk
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 participants at risk
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 participants at risk
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 participants at risk
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 participants at risk
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 participants at risk
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Fatigue
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Hepatobiliary disorders
Hepatic failure
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Encephalitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Escherichia bacteraemia
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Infected fistula
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Septic shock
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Gastroenteritis radiation
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
75.0%
3/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
37.5%
3/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
41.7%
5/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
4/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
5/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
71.4%
5/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
4/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
6/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
66.7%
4/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericarditis malignant
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Secondary cerebellar degeneration
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Seizure
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Psychiatric disorders
Delirium
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
Other adverse events
| Measure |
Escalation Part 1: BMS 20 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 20mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 40 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 40mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 80 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 80mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 160 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 160mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 1: BMS 320 mg Q2W
n=4 participants at risk
Part 1A is BMS-986178 monotherapy dose escalation. Dosing of BMS-986178 320mg will begin on Day 1 of each cycle and will be administered every 2 week (q2w) for up to 12 cycles.
|
Escalation Part 2 BMS 20 mg + Nivo 240 mg Q2W
n=7 participants at risk
Dosing of BMS-986178 20mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 40 mg + Nivo 240 mg Q2W
n=8 participants at risk
Dosing of BMS-986178 40mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 80 mg + Nivo 240 mg Q2W
n=12 participants at risk
Dosing of BMS-986178 80mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 160 mg + Nivo 240 mg Q2W
n=8 participants at risk
Dosing of BMS-986178 160mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 2: BMS 320 mg + Nivo 240 mg Q2W
n=8 participants at risk
Dosing of BMS-986178 320mg and Nivolumab flat dose of 240 mg will be administered every 2 weeks (q2w) starting on Day 1 of each cycle for up to 12 cycles.
|
Escalation Part 3: BMS 20 mg + Ipi 1 mg/kg Q3W
n=4 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 20mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 40 mg + Ipi 1 mg/kg Q3W
n=10 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 40mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 80 mg + Ipi 1 mg/kg Q3W
n=7 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 80mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 160 mg + Ipi 1 mg/kg Q3W
n=8 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 160mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Escalation Part 3: BMS 320 mg + Ipi 1 mg/kg Q3W
n=6 participants at risk
Each treatment cycle will be 3 weeks in length. BMS-986178 320mg will be administered q3w starting on Cycle 1 Day 1, up to and including 8 cycles. Ipilimumab will be administered at a dose of 1 mg/kg q3w starting on Day 1 for 4 cycles. Only BMS-986178 will be administered in the last 4 cycles.
|
Expansion Part 2C: BMS 80 mg + Nivo 240 mg Q2W (BDC)
n=18 participants at risk
Participants with bladder cancer receive BMS-986178 (80 mg) and Nivolumab administered at a flat dose of 240 mg. Each treatment cycle will be 2 weeks in length and study drugs will be administered every 2 weeks starting on Day 1 of each cycle for up to 12 cycles.
|
Schedule and Dose Exploration Part 4: BMS 80 mg + Nivo 480 mg Q4W
n=12 participants at risk
Combination arm of BMS-986178 (80 mg) with nivolumab (480 mg) to be administered every 4 weeks (q4w).
|
Schedule and Dose Exploration Part 5: BMS 80 mg + Ipi 3 mg/kg Q3W
n=6 participants at risk
Combination arm of BMS-986178 (80 mg) with Ipilimumab 3 mg/kg administered every 3 weeks (q3w) for 4 doses, followed by monotherapy with BMS-986178 (maintenance therapy).
|
Safety Part 6A: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=7 participants at risk
Participants with renal cell carcinoma (RCC) recieve BMS-986178 (40mg) administered at a flat dose in combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4, followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 (40 mg) and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Expansion Part 6B: BMS 40 mg + Nivo 240 mg + Ipi 1 mg/kg Q3W / BMS 40 mg + Nivo 480 mg Q4W (RCC)
n=1 participants at risk
Participants with renal cell carcinoma (RCC) receive BMS-986178 (40mg) administered combination with nivolumab (240 mg) and ipilimumab (1 mg/kg) every 3 weeks (q3w) during Cycles 1 to 4 followed by maintenance therapy (Cycle 5 and beyond) in which BMS-986178 and nivolumab (480 mg) will be administered every 4 weeks (q4w). Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Safety Cohort Part 7A: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=6 participants at risk
BMS-986178 will be administered at a flat dose of 40 mg (q2w) in combination with nivolumab (240 mg; q2w) and ipilimumab (1 mg/kg; q6w) for four 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle. If participants continue for additional cycles, past cycle 4, all study drugs (BMS-986178/nivolumab/ipilimumab) will continue for all cycles.
|
Expansion Part 7B: BMS 40mg Q2W + Nivo 240 mg Q2W + Ipi 1 mg/kg Q6W (NSCLC)
n=9 participants at risk
Participants with non-small cell lung cancer (NSCLC) receive BMS-986178 (40 mg) in combination with nivolumab 240 mg every 2 weeks (q2w) and ipilimumab 1 mg/kg every 6 weeks (q6w) for four, 6-week cycles. Study drugs will be administered accordingly starting on Day 1 of each cycle.
|
Schedule and Dose Exploration Part 8: Cohort 1- BMS 20 mg Q12W + Nivo 480 mg Q4W
n=2 participants at risk
BMS-986178 (20 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 2- BMS 40 mg Q12W + Nivo 480 mg Q4W
n=2 participants at risk
BMS-986178 (40 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 3- BMS 80 mg Q12W + Nivo 480 mg Q4W
n=2 participants at risk
BMS-986178 (80 mg) will be administered as a flat dose every 12 weeks (q12w) in combination with nivolumab flat dose (480 mg) every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length starting on Day 1 of each cycle. There will be up to 9 cycles, to allow for 24 months of treatment. A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab and BMS-986178.
|
Schedule and Dose Exploration Part 8: Cohort 4- Nivo 480 mg Q4W
n=2 participants at risk
Nivolumab monotherapy will be administered as a flat dose of 480 mg every 4 weeks (q4w). Each treatment cycle will be 12 weeks in length and will be dosed for up to 9 cycles, 24 months of dosing. Treatment will be given on Day 1, Day 29 and 57 of each cycle. . A tetanus vaccine (Tdap preferred, Td or equivalent after discussion with the medical monitor) will be administered first on Cycle 1 Day 1 prior to administration of nivolumab monotherapy.
|
Exploration Part 9 Cohort 1: BMS 40 mg Q4W + Nivo 480 mg Q4W + DRibble Vaccine
n=1 participants at risk
Cohort 1: Cyclophosphamide 300 mg/m2 was administered 3 days prior to C1D1. DPV-001 1 mg was given on C1D1 intranodal then intradermal on C1D8, C1D15, C2D1, C2D15, C3D1, C4D1, C5D1, C6D1, C9D1 and C12D1. Nivolumab 240 mg was administered on C1D15 followed by nivolumab 480 mg was Q4W on day 1 of cycles 2-26. BMS-986178 40 mg infusion was administered on day 1 of cycles 1-6, 9, and 12. Each treatment cycle is 4 weeks and there are up to 26 cycles.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
3/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
2/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
4/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
37.5%
3/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
5/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
3/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
3/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
2/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
20.0%
2/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
4/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
42.9%
3/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
2/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Retching
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
3/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
20.0%
2/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
3/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
66.7%
4/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Swollen tongue
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
20.0%
2/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Asthenia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
3/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Axillary pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Chest pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Chills
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
3/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Early satiety
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Fatigue
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
62.5%
5/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
4/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
20.0%
2/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
38.9%
7/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
3/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
66.7%
4/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
42.9%
3/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
44.4%
4/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Feeling cold
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Gait disturbance
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Injury associated with device
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Localised oedema
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Malaise
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Mass
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Nodule
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Oedema peripheral
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
4/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
41.7%
5/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
40.0%
4/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
4/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
3/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Swelling face
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Candida infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Erysipelas
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Nail infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Peritonitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Sputum purulent
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Rash pustular
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
2/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Sepsis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
2/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Infections and infestations
Wound infection
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
37.5%
3/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Ammonia increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Amylase increased
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
3/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
42.9%
3/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Injury, poisoning and procedural complications
Vascular access site occlusion
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
37.5%
3/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood chloride increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood chloride decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
27.8%
5/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood glucose increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Lymph node palpable
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Platelet count increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Urine output decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Lipase increased
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
3/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Weight increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Urine protein/creatinine ratio increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Investigations
Weight decreased
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
20.0%
2/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
87.5%
7/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
20.0%
2/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
37.5%
3/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
3/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
3/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
3/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
2/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
3/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
3/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
37.5%
3/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
2/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
42.9%
3/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
4/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
30.0%
3/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
37.5%
3/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
44.4%
8/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
41.7%
5/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
3/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
2/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Ear and labyrinth disorders
Vertigo
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Endocrine disorders
Hypothyroidism
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Blepharospasm
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Cataract
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Conjunctivitis allergic
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Eyelid rash
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Macular degeneration
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Vision blurred
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
3/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Musculoskeletal and connective tissue disorders
Weight bearing difficulty
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphangiosis carcinomatosa
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Aphasia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
37.5%
3/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Secondary cerebellar degeneration
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
2/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Renal disorder
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Reproductive system and breast disorders
Scrotal oedema
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Reproductive system and breast disorders
Scrotal pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
2/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
44.4%
4/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
2/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
2/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
20.0%
2/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
4/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
1/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
55.6%
5/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
3/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Autoimmune dermatitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
28.6%
2/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
30.0%
3/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
3/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
3/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
55.6%
5/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
100.0%
2/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
20.0%
2/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
5.6%
1/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
33.3%
2/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
22.2%
2/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
1/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
50.0%
1/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Embolism
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Embolism venous
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
10.0%
1/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
8.3%
1/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
11.1%
2/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
25.0%
1/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
14.3%
1/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
16.7%
1/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Phlebitis
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/4 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/10 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
12.5%
1/8 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/18 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/12 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/7 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/6 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/9 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/2 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
0.00%
0/1 • From first dose to 100 days post last dose (up to 2.5 years) All Cause Mortality from first dose to study completion (up to approximately 4 years 5 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER