Trial Outcomes & Findings for Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma (NCT NCT02432274)
NCT ID: NCT02432274
Last Updated: 2023-07-11
Results Overview
RD was defined as the dose that had a dose limiting toxicity (DLT) rate closest to the targeted 20% rate. DLT was an adverse drug reaction and was assessed according to common terminology criteria for adverse events (CTCAE) version (v) 4.03 defined as 1) Grade 4 neutropenia for greater than or equal to (\>=) 7 days, 2) Grade \>=3 thrombocytopenia with bleeding, or lasting greater than (\>) 7 days, 3) Grade \>=3 febrile neutropenia, 4) Next course of chemotherapy delayed for \>=7 days, 5) Grade \>=3 non-hematologic toxicity persisting \>7 days optimal supportive care, 6) Grade 4 hypertension, confirmed systolic or diastolic blood pressure \>25 millimeters of mercury (mmHg) above the 95th percentile for age, or an elevated diastolic blood pressure (that is, \>95th percentile for age) not controlled by a single antihypertensive medication within 14 days of use, 7) Grade 3 proteinuria, 8) Any recurrent Grade 2 non-hematological toxicity requiring \>=2 interruption and dose reductions.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
117 participants
Primary outcome timeframe
Cycle 1 (28 days)
Results posted on
2023-07-11
Participant Flow
Participants took part at 19 investigative sites in France, Germany, Italy, Spain, United Kingdom and the United States. Total 117 participants were enrolled and screened, of which 20 participants were screen failures and 97 participants received study treatment.
Prior to entering Cohort 1, some participants aged 2 to less than (\<) 6 years underwent a run-in period and received lenvatinib 5 milligram per square meter (mg/m\^2) per body surface area (BSA) as capsules or suspension once daily for 21 days.
Participant milestones
| Measure |
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
Participants(age group 2 to\<6 years and 6 to\<18 years)with relapsed or refractory solid malignant tumors received lenvatinib 11mg/m\^2(per BSA, daily dose capped at 24 milligram per day\[mg/day\])as capsules or suspension(lenvatinib capsules dissolved in water/apple juice for participants who were unable to swallow capsules and given as suspension),orally,once daily on Days 1 to 28 of each treatment cycle until progressive disease(PD),intolerable toxicity,participant noncompliance with safety/efficacy assessments,initiation of another anticancer therapy,voluntary discontinuation by participant at any time,or study termination by sponsor,whichever occurred first. Eligible participants of age group 2 to\<6 years first underwent 21days run-in period with lenvatinib 5mg/m\^2,once daily before receiving lenvatinib11 mg/m\^2 in Cycle1 in Cohort1. Duration of each treatment cycle in Cohort1=28 days.After determining recommended dose(RD)in Cohort1,participants were enrolled in Cohorts 2A,2B and 3A.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
Participants (age group 2 to \<6 years and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to \<6 years first underwent 21-days run-in period with lenvatinib 5 mg/m\^2, once daily before receiving lenvatinib 14 mg/m\^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days. After determining the RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
|
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
Participants with 131 iodine-refractory differentiated thyroid cancer (DTC) received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20 percent \[%\] lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 milligram per square meter per day (mg/m\^2/day) intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
9
|
11
|
1
|
31
|
7
|
15
|
20
|
|
Overall Study
Underwent Run-in Period
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Treated (Safety Population)
|
5
|
11
|
7
|
1
|
31
|
11
|
11
|
20
|
|
Overall Study
COMPLETED
|
1
|
3
|
4
|
1
|
2
|
0
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
6
|
7
|
0
|
29
|
7
|
10
|
16
|
Reasons for withdrawal
| Measure |
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
Participants(age group 2 to\<6 years and 6 to\<18 years)with relapsed or refractory solid malignant tumors received lenvatinib 11mg/m\^2(per BSA, daily dose capped at 24 milligram per day\[mg/day\])as capsules or suspension(lenvatinib capsules dissolved in water/apple juice for participants who were unable to swallow capsules and given as suspension),orally,once daily on Days 1 to 28 of each treatment cycle until progressive disease(PD),intolerable toxicity,participant noncompliance with safety/efficacy assessments,initiation of another anticancer therapy,voluntary discontinuation by participant at any time,or study termination by sponsor,whichever occurred first. Eligible participants of age group 2 to\<6 years first underwent 21days run-in period with lenvatinib 5mg/m\^2,once daily before receiving lenvatinib11 mg/m\^2 in Cycle1 in Cohort1. Duration of each treatment cycle in Cohort1=28 days.After determining recommended dose(RD)in Cohort1,participants were enrolled in Cohorts 2A,2B and 3A.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
Participants (age group 2 to \<6 years and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to \<6 years first underwent 21-days run-in period with lenvatinib 5 mg/m\^2, once daily before receiving lenvatinib 14 mg/m\^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days. After determining the RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
|
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
Participants with 131 iodine-refractory differentiated thyroid cancer (DTC) received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20 percent \[%\] lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 milligram per square meter per day (mg/m\^2/day) intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Death
|
2
|
6
|
7
|
0
|
27
|
7
|
9
|
14
|
|
Overall Study
Withdrawal of Consent
|
0
|
0
|
0
|
0
|
2
|
0
|
1
|
2
|
Baseline Characteristics
Study of Lenvatinib in Children and Adolescents With Refractory or Relapsed Solid Malignancies and Young Adults With Osteosarcoma
Baseline characteristics by cohort
| Measure |
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
n=3 Participants
Participants (age group 2 to \<6 years and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to \<6 years first underwent 21-days run-in period with lenvatinib 5 mg/m\^2, once daily before receiving lenvatinib 11 mg/m\^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
n=9 Participants
Participants (age group 2 to \<6 years and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Eligible participants of age group 2 to \<6 years first underwent 21-days run-in period with lenvatinib 5 mg/m\^2, once daily before receiving lenvatinib 14 mg/m\^2 in Cycle 1 in Cohort 1. Duration of each treatment cycle in Cohort 1=28 days. After determining RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=11 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days. After determining the RD in Cohort 1, participants were enrolled in Cohorts 2A, 2B and 3A.
|
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
n=1 Participants
Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=31 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=15 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days. After determining the RD in Cohort 3A, participants were enrolled in Cohort 3B.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
2 to <6 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
|
Age, Customized
6 to <18 years
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
24 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
77 Participants
n=42 Participants
|
|
Age, Customized
18 to <=25 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
43 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
54 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
16 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=24 Participants
|
47 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
34 Participants
n=42 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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
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
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
13 Participants
n=24 Participants
|
64 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
6 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
27 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (28 days)Population: Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.
RD was defined as the dose that had a dose limiting toxicity (DLT) rate closest to the targeted 20% rate. DLT was an adverse drug reaction and was assessed according to common terminology criteria for adverse events (CTCAE) version (v) 4.03 defined as 1) Grade 4 neutropenia for greater than or equal to (\>=) 7 days, 2) Grade \>=3 thrombocytopenia with bleeding, or lasting greater than (\>) 7 days, 3) Grade \>=3 febrile neutropenia, 4) Next course of chemotherapy delayed for \>=7 days, 5) Grade \>=3 non-hematologic toxicity persisting \>7 days optimal supportive care, 6) Grade 4 hypertension, confirmed systolic or diastolic blood pressure \>25 millimeters of mercury (mmHg) above the 95th percentile for age, or an elevated diastolic blood pressure (that is, \>95th percentile for age) not controlled by a single antihypertensive medication within 14 days of use, 7) Grade 3 proteinuria, 8) Any recurrent Grade 2 non-hematological toxicity requiring \>=2 interruption and dose reductions.
Outcome measures
| Measure |
Cohort 1: All Participants
n=23 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 1: Recommended Dose (RD) of Lenvatinib
|
14 milligram per square meter (mg/m^2)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From date of first dose of study drug until first documentation of PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)Population: Full analysis set included all enrolled participants who did not fail study screening.
OR was defined as participants with best overall response (BOR) of CR or PR as assessed by investigator based on response evaluation criteria in solid tumors (RECIST) version (v) 1.1. For OR, the BOR was defined as the best response (CR or PR for \>4 weeks) recorded from the start of the treatment until PD or death whichever occurred first. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameter (SOD) of target lesions, taking as reference the baseline sum diameters. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Cohort 1: All Participants
n=1 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 2A: Number of Participants With Objective Response (OR) of Complete Response (CR) or Partial Response (PR)
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose of study drug until PD or death, whichever occurred first (until the data cut-off date, 31 May 2019)Population: Full analysis set included all enrolled participants who did not fail study screening.
BOR was defined as the best response of CR or PR for \>4 weeks or SD for \>=7 weeks recorded from the start of the treatment until PD or death, whichever occurred first based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
Outcome measures
| Measure |
Cohort 1: All Participants
n=1 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 2A: Number of Participants With Best Overall Response (BOR)
Complete Response
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2A: Number of Participants With Best Overall Response (BOR)
Partial Response
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2A: Number of Participants With Best Overall Response (BOR)
Stable Disease
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At Month 4Population: PFS-4 evaluable set included all participants treated with study drug for at least 4 months or those who died or radiologically progressed within 4 months after first dose, or received anticancer treatment within 4 months after first dose.
Progression free survival at Month 4 (PFS-4) rate was defined as the percentage of participants who were alive and without PD at Month 4 after the first dose of study drug, based on RECIST v1.1, using a binomial proportion with corresponding 95% confidence interval (CI). PD: \>= 20% increase in sum of diameters of target lesions, reference-smallest sum recorded in study (sum at baseline if that was smallest). Sum of diameters must have absolute increase of \>=5 mm. Appearance of \>=1 new lesions also considered PD.
Outcome measures
| Measure |
Cohort 1: All Participants
n=28 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=15 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 2B and 3B: Progression-free Survival (PFS) Rate at Month 4
|
32.1 percentage of participants
Interval 15.9 to 52.4
|
66.7 percentage of participants
Interval 38.4 to 88.2
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.
RD of lenvatinib when given in combination with ifosfamide and etoposide was defined as dose that resulted in no more than 1 DLT per 6 participants,or hematologic DLT in 1 participant and nonhematologic DLT in another participant per 6 participants,upon repeating same dose level.DLT was adverse drug reaction and assessed per CTCAE v4.03 defined as 1)Grade 4 neutropenia for \>=10 days,2)Grade \>=3 thrombocytopenia with bleeding,or lasting \>=10 days,3)Grade \>=3 febrile neutropenia lasting \>=7 days,4)Next course of chemotherapy delayed for \>=7 days,5)Grade \>=3 nonhematologic toxicity persisting \>7 days despite optimal supportive care,6)Grade 4 hypertension,confirmed systolic or diastolic blood pressure \>25 mmHg above 95th percentile for age,or elevated diastolic blood pressure(\>95th percentile for age)not controlled by single antihypertensive medication within 14 days use,7)Grade 3 proteinuria,8)Any recurrent Grade 2 nonhematological toxicity requiring \>=2 interruption and dose reductions.
Outcome measures
| Measure |
Cohort 1: All Participants
n=22 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 3A: Recommended Dose (RD) of Lenvatinib When Given in Combination With Etoposide and Ifosfamide
|
14 milligram per square meter (mg/m^2)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)Population: Full analysis set included all enrolled participants who did not fail study screening. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
BOR: best response of CR or PR for \>4 weeks or SD for \>=7 weeks from first dose, recorded from start of treatment until PD or death, whichever occurred first based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have reduction in their short axis \<10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. PD was defined as: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. Not evaluable (NE) means BOR of NE or SD of \<7 weeks duration. Unknown means no data were available on the case report form.
Outcome measures
| Measure |
Cohort 1: All Participants
n=3 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=9 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=10 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=30 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=14 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=18 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)
Stable Disease
|
2 Participants
|
5 Participants
|
4 Participants
|
13 Participants
|
3 Participants
|
10 Participants
|
9 Participants
|
—
|
|
Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)
Progressive Disease
|
1 Participants
|
2 Participants
|
4 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Cohorts 1, 2B, 3A, and 3B: Number of Participants With Best Overall Response (BOR)
Not Evaluable or Unknown
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: From date of first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)Population: Full analysis set included all enrolled participants who did not fail study screening. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
ORR was defined as the percentage of participants with a BOR of CR or PR for \>4 weeks or SD for \>=7 weeks as assessed by investigator based on RECIST v1.1, recorded from start of study treatment until PD or death whichever occurred first. CR was defined as the disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR was defined as at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. 95% CI of the ORR were calculated according to Clopper and Pearson method.
Outcome measures
| Measure |
Cohort 1: All Participants
n=3 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=9 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=10 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=30 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=14 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=18 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2B, 3A, and 3B: Objective Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 70.8
|
0 percentage of participants
Interval 0.0 to 33.6
|
0 percentage of participants
Interval 0.0 to 30.8
|
6.7 percentage of participants
Interval 0.8 to 22.1
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
0 percentage of participants
Interval 0.0 to 23.2
|
16.7 percentage of participants
Interval 3.6 to 41.4
|
—
|
SECONDARY outcome
Timeframe: First documentation of CR/PR until first documentation of PD (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)Population: Full analysis set included all enrolled participants who did not fail study screening. Here "overall number of participants analyzed, N" signifies participants who were evaluable for this measure. Here, "N" for Cohort 1 (Lenvatinib 11, 14, 17 mg/m\^2) and Cohort 3A (Lenvatinib 14 mg/m\^2) is zero as there were no events of CR or PR in these arms.
DOR was defined as time in months from the first documentation confirmed CR or PR until the first documentation of confirmed PD as assessed by investigator based on RECIST v1.1. CR: disappearance of all target and non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target or non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. PD: at least 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the smallest sum and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. 95% CI for the median were calculated according to Brookmeyer and Crowley method.
Outcome measures
| Measure |
Cohort 1: All Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=2 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=2 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=3 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Duration of Response (DOR)
|
—
|
—
|
—
|
1.9 months
95% CI could not be estimated as insufficient number of participants were available for analysis.
|
4.6 months
95% CI could not be estimated as insufficient number of participants were available for analysis.
|
NA months
Median and 95% CI could not be estimated because all participants were censored from the analysis.
|
—
|
NA months
Median and 95% CI could not be estimated because all participants were censored from the analysis.
|
SECONDARY outcome
Timeframe: From first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)Population: Full analysis set included all enrolled participants who did not fail study screening.
Participants were defined as having disease control if they had a BOR of CR or PR for \>4 weeks, or SD (minimum duration from first dose to SD \>=7 weeks) or if participants had a BOR of CR or Non-CR/Non-PD (minimum duration from first dose to Non-CR/Non-PD \>=7 weeks) per RECIST v1.1, recorded from first dose until PD or death whichever occurred first. CR: disappearance of all target/non-target lesions (non-lymph nodes). All pathological lymph nodes (target/non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference smallest SOD. Non-CR/Non-PD: persistence of 1 or more non-target lesions, maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Cohort 1: All Participants
n=3 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=9 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=11 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=31 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=15 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Who Experienced Disease Control
|
2 Participants
|
5 Participants
|
5 Participants
|
1 Participants
|
16 Participants
|
5 Participants
|
11 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)Population: Full analysis set included all enrolled participants who did not fail study screening.
Participants were defined as having clinical benefit if they had a BOR of CR or PR for \>4 weeks or durable SD (lasting \>=23 weeks) or if participants had a BOR of CR or durable Non-CR/Non-PD (lasting \>=23 weeks) as per RECIST v1.1, recorded from first dose until PD or death whichever occurred first. CR: disappearance of all target/non-target lesions (non-lymph nodes). All pathological lymph nodes (whether target/non-target) must have a reduction in their short axis \<10 mm. PR: at least a 30% decrease in the SOD of target lesions, taking as reference the baseline sum diameters. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SOD. Non-CR/Non-PD:persistence of 1 or more non-target lesions and maintenance of tumor marker level above the normal limits.
Outcome measures
| Measure |
Cohort 1: All Participants
n=3 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=9 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=11 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=31 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=15 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Experienced Clinical Benefit
|
0 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
7 Participants
|
4 Participants
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug until PD or death, whichever occurred first (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)Population: Full analysis set included all enrolled participants who did not fail study screening.
PFS was defined as the time (in months) from the date of first dose of study drug to the date of first documentation of PD or date of death, whichever occurred first, based on RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the baseline SOD of target lesions. 95% CI of median were calculated according to Brookmeyer and Crowley method.
Outcome measures
| Measure |
Cohort 1: All Participants
n=3 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=9 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=11 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=31 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=15 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Progression-free Survival (PFS)
|
3.7 months
Interval 0.5 to 5.0
|
6.3 months
Interval 0.6 to 10.6
|
5.5 months
Interval 1.4 to 11.3
|
5.5 months
95% CI could not be estimated as insufficient number of participants were available for analysis.
|
3.0 months
Interval 1.8 to 5.4
|
7.1 months
Interval 2.1 to
Upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.
|
12.0 months
Interval 11.1 to 16.1
|
6.9 months
Interval 4.2 to
Upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.
|
SECONDARY outcome
Timeframe: From first dose of study drug until PD (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)Population: Full analysis set included all enrolled participants who did not fail study screening.
TTP was defined as the time from the date of first dose of study drug to the date of first documentation of PD based on RECIST 1.1. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the SOD of target lesions, taking as reference the baseline SOD of target lesions. 95% CI of median were calculated according to Brookmeyer and Crowley method.
Outcome measures
| Measure |
Cohort 1: All Participants
n=3 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=9 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=11 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=31 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=15 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Time to Progression (TTP)
|
3.7 months
Interval 0.5 to 5.0
|
6.3 months
Interval 0.6 to 10.6
|
5.5 months
Interval 1.4 to 11.3
|
5.5 months
95% CI could not be estimated as insufficient number of participants were available for analysis.
|
3.0 months
Interval 1.8 to 5.4
|
7.1 months
Interval 2.1 to
Upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.
|
12.0 months
Interval 11.1 to 16.1
|
6.9 months
Interval 4.2 to
Upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.
|
SECONDARY outcome
Timeframe: From first dose of study drug until death (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)Population: Full analysis set included all enrolled participants who did not fail study screening.
OS was defined as the time from the date of the first dose of study drug until the date of death from any cause. Participants who are lost to follow-up and those who are alive at the date of data cutoff were censored at the date the participant was last known to be alive (or the data cutoff date). 95% CI of median were calculated according to Brookmeyer and Crowley method.
Outcome measures
| Measure |
Cohort 1: All Participants
n=3 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=9 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=11 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=31 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=15 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Overall Survival (OS)
|
8.1 months
Interval 3.8 to
Upper limit of 95% CI could not be estimated due to low number of participants with events.
|
7.4 months
Interval 1.3 to
Upper limit of 95% CI could not be estimated due to low number of participants with events.
|
7.7 months
Interval 2.7 to
Upper limit of 95% CI could not be estimated due to low number of participants with events.
|
6.1 months
95% CI could not be estimated as insufficient number of participants were available for analysis.
|
10.0 months
Interval 5.6 to 12.3
|
13.6 months
Interval 2.4 to 28.0
|
NA months
Interval 8.8 to
Median and upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.
|
NA months
Interval 7.3 to
Median and upper limit of 95% CI could not be estimated because high number of participants were censored from the analysis.
|
SECONDARY outcome
Timeframe: From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)Population: Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.
Number of participants with TEAEs (serious and non-serious adverse events) and SAEs were reported based on their safety assessments of hematology, clinical chemistry, proximal tibial growth, fecal occult blood, physical examinations, regular measurement of vital signs and electrocardiogram parameter values.
Outcome measures
| Measure |
Cohort 1: All Participants
n=5 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=7 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=31 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
3 Participants
|
7 Participants
|
5 Participants
|
1 Participants
|
21 Participants
|
7 Participants
|
9 Participants
|
16 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
5 Participants
|
11 Participants
|
7 Participants
|
1 Participants
|
29 Participants
|
11 Participants
|
11 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 4 years 7 monthsPopulation: Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
An aliquot of the urine samples were collected to analyze protein by dipstick method, microscopic examination (if protein was abnormal). The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters of urine protein can be read as "negative, Trace, plus (+) 1, +2, +3 and +4" indicating proportional concentrations in the urine sample. The plus sign increases with a higher level of proteins in the urine.
Outcome measures
| Measure |
Cohort 1: All Participants
n=5 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=7 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=30 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +3, Worst Post baseline: Negative
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +3, Worst Post baseline: +2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Negative, Worst Post baseline: Trace
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Negative, Worst Post baseline: +1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
7 Participants
|
1 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Trace, Worst Post baseline: +1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Trace, Worst Post baseline: +2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +1, Worst Post baseline: Trace
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +1, Worst Post baseline: +2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +1, Worst Post baseline: +3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Negative, Worst Post baseline: +3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Trace, Worst Post baseline: Negative
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Trace, Worst Post baseline: Trace
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +1, Worst Post baseline: Negative
|
2 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +1, Worst Post baseline: +1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Negative, Worst Post baseline: Negative
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +2, Worst Post baseline: Negative
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +3, Worst Post baseline: +1
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +3, Worst Post baseline: Trace
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +4, Worst Post baseline: Trace
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +4, Worst Post baseline: +1
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Negative, Worst Post baseline: +2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
6 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Trace, Worst Post baseline: +3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: Negative, Worst Post baseline: +4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Measurements on Urine DipStick for Proteinuria
Baseline: +1, Worst Post baseline: +4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 4 years 7 monthsPopulation: Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
Lansky Performance Play Scale rates a child's activity level for \<16 years of age. Scores on scale range from 0 (unresponsive) to 100 ( fully active, normal), where 100=fully active, normal; 90=minor restrictions in physically strenuous activity; 80=active, but tires more quickly; 70=both greater restriction of and less time spent in play activity; 60=up and around, but minimal active play, keeps busy with quieter activities; 50=gets dressed, but lies around much of day, no active play, able to participant in quiet play and activities; 40=mostly in bed, participates in quiet activities; 30=in bed, needs assistance even for quiet play; 20=often sleeping, play entirely limited to very passive activities; 10=no play, does not get out of bed; 0=unresponsive. Higher score indicates more activity and lower indicates less or no activity.
Outcome measures
| Measure |
Cohort 1: All Participants
n=3 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=7 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=15 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=6 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=7 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=9 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score:100%, Worst Postbaseline score:90%
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 80%, Worst Postbaseline score: 40%
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 70%, Worst Postbaseline score: 80%
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 80%, Worst Postbaseline score: 80%
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 100%, Worst Postbaseline score:80%
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 60%, Worst Postbaseline score: 60%
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 90%, Worst Postbaseline score:100%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 80%, Worst Postbaseline score: 50%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 80%, Worst Postbaseline score: 70%
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 90%, Worst Postbaseline score: 70%
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 90%, Worst Postbaseline score: 80%
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score:100%, Worst Postbaseline score:100%
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 90%, Worst Postbaseline score: 90%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 90%, Worst Postbaseline score: 60%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 70%, Worst Postbaseline score: 70%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 100%, Worst Postbaseline score:70%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 70%, Worst Postbaseline score: 60%
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 80%, Worst Postbaseline score: 60%
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Lansky Performance Play Score
Baseline score: 100%, Worst Postbaseline score:60%
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to approximately 4 years 7 monthsPopulation: Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.
KPS: compare effectiveness of medicine for disease and assess outcomes in participants. KPS Scores: recorded on 11 point scale (0, 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100%), where 0=Dead; 10=moribund, fatal processes progressing rapidly; 20=very sick, hospital admission necessary, active supportive treatment necessary; 30=severely disabled, hospital admission is indicated although death not imminent; 40=disabled, requires special care/assistance; 50=requires considerable assistance/frequent medical care; 60=requires occasional assistance, but is able to care for personal needs; 70=cares for self, unable to carry normal activity or active work; 80=normal activity with effort, some signs of disease; 90=able to carry on normal activity, minor signs of disease; 100=normal no complaints, no evidence of disease. Lower score, worse survival for most serious illnesses.
Outcome measures
| Measure |
Cohort 1: All Participants
n=1 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=12 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=3 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=9 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score: 100%, Worst Postbaseline score:80%
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score: 70%, Worst Postbaseline score: 70%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score: 90%, Worst Postbaseline score: 70%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score: 100%, Worst Postbaseline score:70%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score: 90%, Worst Postbaseline score: 80%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score: 100%, Worst Postbaseline score:90%
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score: 80%, Worst Postbaseline score: 80%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score: 90%, Worst Postbaseline score: 60%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score:100%, Worst Postbaseline score:100%
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Shift From Baseline to Worst Post Baseline Score in Karnofsky Performance Status (KPS) Scores
Baseline score: 90%, Worst Postbaseline score: 90%
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Cohorts 1, 2A, 2B: Cycle(C)1 Day(D)1: 0.5-4 hours (h), 6-10 h post-dose, C1D15: pre-dose, 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dose; Cohorts 3A, 3B: C1D1: 0.5-4 h, 6-10 h post-dose, C2D1: pre-dose, 2-12 h post-dosePopulation: Pharmacokinetic (PK) Analysis Set included all participants who had received any study drug and had evaluable PK data. Here "number analyzed, n" signifies participants who were evaluable for this outcome measure at given time points.
Duration of each cycle for Cohorts 1, 2A, 2B is 28 days. Duration of each cycle for Cohorts 3A, 3B is 21 days.
Outcome measures
| Measure |
Cohort 1: All Participants
n=5 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=7 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=31 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
Cycle 1 Day 15: Pre-dose
|
46.9 nanogram per milliliter (ng/mL)
Standard Deviation 11.01
|
59.1 nanogram per milliliter (ng/mL)
Standard Deviation 29.19
|
96.9 nanogram per milliliter (ng/mL)
Standard Deviation 66.10
|
56.2 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
67.0 nanogram per milliliter (ng/mL)
Standard Deviation 53.78
|
—
|
—
|
—
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
Cycle 1 Day 15: 6-10 hours
|
351.8 nanogram per milliliter (ng/mL)
Standard Deviation 157.15
|
375.8 nanogram per milliliter (ng/mL)
Standard Deviation 121.21
|
413.0 nanogram per milliliter (ng/mL)
Standard Deviation 221.47
|
247 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
322.9 nanogram per milliliter (ng/mL)
Standard Deviation 138.87
|
—
|
—
|
—
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
Cycle 2 Day 1: Pre-dose
|
58.1 nanogram per milliliter (ng/mL)
Standard Deviation 19.58
|
61.6 nanogram per milliliter (ng/mL)
Standard Deviation 60.61
|
97.9 nanogram per milliliter (ng/mL)
Standard Deviation 77.08
|
59.8 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
66.8 nanogram per milliliter (ng/mL)
Standard Deviation 62.50
|
51.7 nanogram per milliliter (ng/mL)
Standard Deviation 44.23
|
76.1 nanogram per milliliter (ng/mL)
Standard Deviation 63.25
|
50.4 nanogram per milliliter (ng/mL)
Standard Deviation 65.10
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
Cycle 2 Day 1: 2-12 hours
|
502.4 nanogram per milliliter (ng/mL)
Standard Deviation 360.71
|
440.7 nanogram per milliliter (ng/mL)
Standard Deviation 229.29
|
339.2 nanogram per milliliter (ng/mL)
Standard Deviation 212.44
|
102 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
382.4 nanogram per milliliter (ng/mL)
Standard Deviation 217.49
|
205.6 nanogram per milliliter (ng/mL)
Standard Deviation 134.66
|
237.4 nanogram per milliliter (ng/mL)
Standard Deviation 124.82
|
275.3 nanogram per milliliter (ng/mL)
Standard Deviation 135.73
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
Cycle 1 Day 1: 0.5-4 hours
|
295.6 nanogram per milliliter (ng/mL)
Standard Deviation 214.01
|
134.8 nanogram per milliliter (ng/mL)
Standard Deviation 145.83
|
52.5 nanogram per milliliter (ng/mL)
Standard Deviation 81.40
|
11.1 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
177.4 nanogram per milliliter (ng/mL)
Standard Deviation 191.03
|
105.2 nanogram per milliliter (ng/mL)
Standard Deviation 131.54
|
111.4 nanogram per milliliter (ng/mL)
Standard Deviation 131.47
|
209.7 nanogram per milliliter (ng/mL)
Standard Deviation 197.66
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
Cycle 1 Day 1: 6-10 hours
|
212.7 nanogram per milliliter (ng/mL)
Standard Deviation 185.98
|
281.9 nanogram per milliliter (ng/mL)
Standard Deviation 137.39
|
238.0 nanogram per milliliter (ng/mL)
Standard Deviation 135.87
|
188 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
289.4 nanogram per milliliter (ng/mL)
Standard Deviation 200.09
|
191.9 nanogram per milliliter (ng/mL)
Standard Deviation 100.69
|
148.5 nanogram per milliliter (ng/mL)
Standard Deviation 122.41
|
164.8 nanogram per milliliter (ng/mL)
Standard Deviation 73.59
|
|
Cohorts 1, 2A, 2B, 3A, and 3B: Plasma Concentrations of Lenvatinib
Cycle 1 Day 15: 0.5-4 hours
|
133.4 nanogram per milliliter (ng/mL)
Standard Deviation 163.37
|
226.6 nanogram per milliliter (ng/mL)
Standard Deviation 204.61
|
191.8 nanogram per milliliter (ng/mL)
Standard Deviation 190.22
|
124 nanogram per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be calculated because only one participant was available for analysis.
|
168.3 nanogram per milliliter (ng/mL)
Standard Deviation 157.67
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 2B: Baseline, Cycle 2-3 Day 1 (Duration of each cycle=28 days); Cohort 3B: Baseline, Cycle 2 Day 1, Cycle 4 Day 1 (Duration of each cycle=21 days)Population: PFS-4 evaluable set: all participants treated with study drug for at least 4 months or those who died or radiologically progressed within 4 months after first dose or received anticancer treatment within 4 months after first dose. "N": participants evaluable for this measure. "n": participants who were evaluable for this measure for specific rows.
Serum biomarkers included Fibroblast Growth Factor (FGF) 19, FGF 21, Vascular Endothelial Growth Factor (VEGF). In this outcome measure, percent change from baseline in serum biomarkers level per "PFS-4, Yes" and "PFS-4, No" have been reported. As per assessment of investigator based on RECIST v1.1, "PFS-4, Yes"= participants evaluable for PFS-4 month and alive and without PD at 4 months from the first dose, "PFS-4, No"=participants evaluable for PFS-4 month and not alive or with PD at 4 months from the first dose.
Outcome measures
| Measure |
Cohort 1: All Participants
n=26 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=13 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C4D1: FGF 21 (PFS-4, Yes)
|
—
|
256.2 percent change
Standard Deviation 323.34
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C4D1: FGF 21 (PFS-4, No)
|
—
|
-1.5 percent change
Standard Deviation NA
Standard deviation could not be estimated as insufficient number of participants were available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C2D1: FGF 19 (PFS-4, Yes)
|
48.7 percent change
Standard Deviation 110.78
|
172.1 percent change
Standard Deviation 211.86
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C2D1: FGF 19 (PFS-4, No)
|
109.9 percent change
Standard Deviation 139.19
|
78.3 percent change
Standard Deviation 203.30
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C3D1: FGF 19 (PFS-4, Yes)
|
47.3 percent change
Standard Deviation 130.42
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C3D1: FGF 19 (PFS-4, No)
|
194.5 percent change
Standard Deviation 180.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C4D1: FGF 19 (PFS-4, Yes)
|
—
|
237.7 percent change
Standard Deviation 204.94
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C4D1: FGF 19 (PFS-4, No)
|
—
|
91.9 percent change
Standard Deviation NA
Standard deviation could not be estimated as insufficient number of participants were available for analysis.
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C2D1: FGF 21 (PFS-4, Yes)
|
-14.9 percent change
Standard Deviation 68.95
|
70.2 percent change
Standard Deviation 138.90
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C2D1: FGF 21 (PFS-4, No)
|
134.3 percent change
Standard Deviation 203.81
|
7.2 percent change
Standard Deviation 48.64
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C3D1: FGF 21 (PFS-4, Yes)
|
55.0 percent change
Standard Deviation 125.51
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C3D1: FGF 21 (PFS-4, No)
|
17.0 percent change
Standard Deviation 88.92
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C2D1: VEGF (PFS-4, Yes)
|
119.9 percent change
Standard Deviation 309.01
|
87.9 percent change
Standard Deviation 105.60
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C2D1: VEGF (PFS-4, No)
|
124.2 percent change
Standard Deviation 212.18
|
95.8 percent change
Standard Deviation 92.53
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C3D1: VEGF (PFS-4, Yes)
|
64.3 percent change
Standard Deviation 153.50
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C3D1: VEGF (PFS-4, No)
|
23.2 percent change
Standard Deviation 69.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cohort 2B, 3B: Percent Change From Baseline in Serum Biomarkers Level
C4D1: VEGF (PFS-4, Yes)
|
—
|
84.3 percent change
Standard Deviation 97.85
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose of study drug until 30 days after last dose of study drug (Cohort 1, Cohort 2A, Cohort 2B: until the data cut-off date, 31 May 2019; Cohort 3A, Cohort 3B: until the data cut-off date, 18 July 2019)Population: Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation.
TEAEs (serious and non-serious), those occurred most frequently have been reported in this outcome measure. "Palmar-plantar E syndrome" refers to Palmar-plantar erythrodysaesthesia syndrome.
Outcome measures
| Measure |
Cohort 1: All Participants
n=5 Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=7 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=31 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=11 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Vomiting
|
1 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
12 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Asthenia
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Fatigue
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Alanine aminotransferase increased
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Blood thyroid stimulating hormone increased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Weight decreased
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Arthralgia
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Myalgia
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Erythema
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Hair color changes
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Hypertension
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
10 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Haematuria
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
4 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Hypokalaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Hypophosphataemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Hypothyroidism
|
3 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
13 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Abdominal pain
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Diarrhea
|
3 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
8 Participants
|
5 Participants
|
5 Participants
|
12 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Nausea
|
1 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
8 Participants
|
7 Participants
|
8 Participants
|
13 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Decreased appetite
|
3 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
13 Participants
|
4 Participants
|
2 Participants
|
5 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Pain in extremity
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Headache
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Proteinuria
|
0 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
7 Participants
|
2 Participants
|
5 Participants
|
8 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Dysphonia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Palmar-plantar E syndrome
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Platelet count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
11 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Back pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Dry skin
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Oral pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Pneumothorax
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Dehydration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Hypoalbuminaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Lethargy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Leukopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Neutrophil count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
9 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Oral dysaesthesia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Oropharyngeal pain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Proctalgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Toxic encephalopathy
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Lymphocyte count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Abdominal pain upper
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Hyperuricemia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Insomnia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Anaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
9 Participants
|
7 Participants
|
15 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Epistaxis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Thrombocytopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Febrile neutropenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Stomatitis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Constipation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
White blood cell count decreased
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
12 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Lymphopenia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Haematochezia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Pyrexia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Wound dehiscence
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Hypocalcaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Dizziness
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Dyspnoea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants With Most Frequent Treatment-emergent Adverse Events (TEAEs) Related to Lenvatinib Exposure
Hyperhidrosis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Cycle length=28 days for Cohorts 1, 2A, 2B; Cycle length=21 days for Cohorts 3A, 3B)Population: Palatability analysis set included all participants who received oral suspension of lenvatinib and answered at least 1 question in the palatability questionnaire case report form.
In acceptability questionnaire, participants were asked to answer the overall acceptability of lenvatinib suspension considering the following elements: taste, appearance, smell and how does it feel in the mouth. Overall acceptability was answered in terms of 7 responses: Super good, really good, good, may be good or may be bad, bad, really bad, super bad. Overall acceptability was the overall acceptance for taste, appearance, smell, and the feeling in mouth. In this measure, number of participants have been reported per their overall acceptability responses.
Outcome measures
| Measure |
Cohort 1: All Participants
Participants (of age group 2 to \<6 years \[following the completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 11 mg/m\^2, 14 mg/m\^2 or 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=2 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=1 Participants
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=1 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=4 Participants
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
Super Good
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
Really Good
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
Good
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
May be Good or May be Bad
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
Bad
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
Really Bad
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohorts 1, 2A, 2B, 3A and 3B: Number of Participants Categorized Based on Overall Acceptability Questionnaire Responses for Suspension of Lenvatinib
Super Bad
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Lenvatinib 5 mg/m^2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
Serious events: 3 serious events
Other events: 5 other events
Deaths: 2 deaths
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
Serious events: 7 serious events
Other events: 11 other events
Deaths: 7 deaths
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
Serious events: 5 serious events
Other events: 7 other events
Deaths: 6 deaths
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
Serious events: 21 serious events
Other events: 29 other events
Deaths: 27 deaths
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
Serious events: 7 serious events
Other events: 11 other events
Deaths: 10 deaths
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
Serious events: 9 serious events
Other events: 11 other events
Deaths: 6 deaths
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
Serious events: 16 serious events
Other events: 20 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Lenvatinib 5 mg/m^2
n=2 participants at risk
Eligible participants of age group 2 to \<6 years first underwent a 21-day run-in period with lenvatinib 5 mg/m\^2, once daily as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension) before receiving lenvatinib 11 mg/m\^2 or 14 mg/m\^2 in Cycle 1 of Cohort 1 (Single-agent Dose-finding).
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
n=5 participants at risk
Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
n=11 participants at risk
Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=7 participants at risk
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
n=1 participants at risk
Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=31 participants at risk
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=11 participants at risk
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=11 participants at risk
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 participants at risk
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Amylase increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood pressure increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Lipase increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
4/20 • Number of events 12 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
12.9%
4/31 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
28.6%
2/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Facial pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
12.9%
4/31 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
15.0%
3/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Arterial thrombosis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Wound infection bacterial
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Brain injury
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
4/20 • Number of events 18 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Transfusion related complication
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
25.0%
5/20 • Number of events 16 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Venoocclusive disease
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Dysmetria
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
Other adverse events
| Measure |
Lenvatinib 5 mg/m^2
n=2 participants at risk
Eligible participants of age group 2 to \<6 years first underwent a 21-day run-in period with lenvatinib 5 mg/m\^2, once daily as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension) before receiving lenvatinib 11 mg/m\^2 or 14 mg/m\^2 in Cycle 1 of Cohort 1 (Single-agent Dose-finding).
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 11 mg/m^2
n=5 participants at risk
Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 11 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 14 mg/m^2
n=11 participants at risk
Participants (age group 2 to \<6 years \[following completion of run-in period\] and 6 to \<18 years) with relapsed or refractory solid malignant tumors received lenvatinib 14 mg/m\^2 (per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by participant at any time, or study termination by sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 1, Single-agent Dose-finding: Lenvatinib 17 mg/m^2
n=7 participants at risk
Participants (of age group 6 to \<18 years) with relapsed or refractory solid malignant tumors received dose of lenvatinib 17 mg/m\^2 (administered per BSA, daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 1=28 days.
|
Cohort 2A, Single-agent Expansion, DTC: Lenvatinib 14 mg/m^2
n=1 participants at risk
Participants with 131 iodine-refractory DTC received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2A=28 days.
|
Cohort2B,Single-agentExpansion,Osteosarcoma:Lenvatinib14mg/m^2
n=31 participants at risk
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administered per BSA with daily dose capped at 24 mg/day) as capsule or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 28 of each treatment cycle as a single agent until PD, intolerable toxicity, participant noncompliance with safety or efficacy assessments, initiation of another anticancer therapy, voluntary discontinuation by the participant at any time, or study termination by the sponsor, whichever occurred first. Duration of each treatment cycle in Cohort 2B=28 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 11 mg/m^2
n=11 participants at risk
Participants with relapsed or refractory osteosarcoma received lenvatinib 11 mg/m\^2 (20% lower than the RD from Cohort 1; administered per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3A, Combination Dose-finding: Lenvatinib 14 mg/m^2
n=11 participants at risk
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3A=21 days.
|
Cohort 3B, Combination Expansion: Lenvatinib 14 mg/m^2
n=20 participants at risk
Participants with relapsed or refractory osteosarcoma received lenvatinib 14 mg/m\^2 (administrated per BSA with daily dose capped at 24 mg/day) as capsules or suspension (lenvatinib capsules were dissolved in water or apple juice for participants who were unable to swallow capsules and given as suspension), orally, once daily on Days 1 to 21 of each treatment cycle in combination with ifosfamide 3000 mg/m\^2/day intravenously and etoposide 100 mg/m\^2/day intravenously on Days 1 to 3 of each treatment cycle for up to a total of 5 cycles as a combination therapy. Duration of each treatment cycle in Cohort 3B=21 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
16.1%
5/31 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
81.8%
9/11 • Number of events 43 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
63.6%
7/11 • Number of events 29 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
75.0%
15/20 • Number of events 77 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 19 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 25 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
8/20 • Number of events 51 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 50 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 54 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
25.0%
5/20 • Number of events 47 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Endocrine disorders
Hypothyroidism
|
50.0%
1/2 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
60.0%
3/5 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
42.9%
3/7 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
41.9%
13/31 • Number of events 17 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
72.7%
8/11 • Number of events 11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
30.0%
6/20 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Eye ulcer
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Papilloedema
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
63.6%
7/11 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
28.6%
2/7 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
29.0%
9/31 • Number of events 27 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 18 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
35.0%
7/20 • Number of events 23 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
12.9%
4/31 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
4/20 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
32.3%
10/31 • Number of events 14 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
35.0%
7/20 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
1/2 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
80.0%
4/5 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
57.1%
4/7 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 12 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
38.7%
12/31 • Number of events 29 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
72.7%
8/11 • Number of events 24 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 14 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
65.0%
13/20 • Number of events 72 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
16.1%
5/31 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
4/20 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
60.0%
3/5 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
42.9%
3/7 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
38.7%
12/31 • Number of events 16 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
72.7%
8/11 • Number of events 28 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
72.7%
8/11 • Number of events 28 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
70.0%
14/20 • Number of events 45 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
12.9%
4/31 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
4/20 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
63.6%
7/11 • Number of events 20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
57.1%
4/7 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.2%
14/31 • Number of events 41 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
81.8%
9/11 • Number of events 28 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
72.7%
8/11 • Number of events 20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
60.0%
12/20 • Number of events 58 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Asthenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
32.3%
10/31 • Number of events 13 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
8/20 • Number of events 28 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Catheter site pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
42.9%
3/7 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
29.0%
9/31 • Number of events 15 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
4/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
12.9%
4/31 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
57.1%
4/7 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
35.5%
11/31 • Number of events 17 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
30.0%
6/20 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Ear infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Influenza
|
50.0%
1/2 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Localised infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Rhinitis
|
100.0%
2/2 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
42.9%
3/7 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
12.9%
4/31 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
28.6%
2/7 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
25.0%
5/20 • Number of events 13 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
28.6%
2/7 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
15.0%
3/20 • Number of events 13 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood urea increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
12.9%
4/31 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Lipase increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
28.6%
2/7 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 14 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 12 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 16 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
55.0%
11/20 • Number of events 86 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Red blood cell sedimentation rate increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Weight decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
60.0%
3/5 • Number of events 13 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
42.9%
3/7 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
35.5%
11/31 • Number of events 17 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
25.0%
5/20 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
80.0%
4/5 • Number of events 14 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
42.9%
3/7 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
48.4%
15/31 • Number of events 26 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
35.0%
7/20 • Number of events 12 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
15.0%
3/20 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
32.3%
10/31 • Number of events 17 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
15.0%
3/20 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
28.6%
2/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
32.3%
10/31 • Number of events 15 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
25.0%
5/20 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
19.4%
6/31 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
32.3%
10/31 • Number of events 14 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
15.0%
3/20 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 12 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
42.9%
3/7 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
29.0%
9/31 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 16 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
15.0%
3/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Cranial nerve paralysis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
42.9%
3/7 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
48.4%
15/31 • Number of events 20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
63.6%
7/11 • Number of events 13 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
30.0%
6/20 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Muscle contractions involuntary
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Phantom pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Pyramidal tract syndrome
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Bladder pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
4/20 • Number of events 12 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 16 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
42.9%
3/7 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
41.9%
13/31 • Number of events 27 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 13 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.0%
9/20 • Number of events 44 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
28.6%
2/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
29.0%
9/31 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
30.0%
6/20 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
19.4%
6/31 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
19.4%
6/31 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
28.6%
2/7 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
12.9%
4/31 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
54.5%
6/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
35.0%
7/20 • Number of events 15 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
1/2 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
50.0%
1/2 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Hair colour changes
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 12 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Spider naevus
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
40.0%
2/5 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
57.1%
4/7 • Number of events 12 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
32.3%
10/31 • Number of events 13 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
25.0%
5/20 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
14.3%
1/7 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Thyroglobulin increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
29.0%
9/31 • Number of events 13 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
25.0%
5/20 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.7%
3/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
15.0%
3/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
12.9%
4/31 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
6.5%
2/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 21 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
15.0%
3/20 • Number of events 20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Diplopia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Eye pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Photophobia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Catheter site bruise
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Catheter site dermatitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Catheter site swelling
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Chills
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Device related thrombosis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Face oedema
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Infusion site irritation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Localised oedema
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Malaise
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Swelling
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Eye infection bacterial
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Paronychia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 6 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood calcium decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 10 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 19 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
30.0%
6/20 • Number of events 15 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
50.0%
10/20 • Number of events 46 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Thyroxine decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Urine output decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
45.5%
5/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
65.0%
13/20 • Number of events 88 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
27.3%
3/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 13 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
4/20 • Number of events 12 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Periostitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Amputation stump pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Migraine
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Sensory disturbance
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dysaesthesia pharynx
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
18.2%
2/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
36.4%
4/11 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
4/20 • Number of events 8 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Scab
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
9.1%
1/11 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Blood and lymphatic system disorders
Acquired antithrombin III deficiency
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Eye disorders
Eye discharge
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Noninfective gingivitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Axillary pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Chest pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Inflammation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Eyelid infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Amylase increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Blood uric acid decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Culture stool positive
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Full blood count decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Lipase decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Limb mass
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 9 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Urine flow decreased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Reproductive system and breast disorders
Genital pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Onychalgia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
10.0%
2/20 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Haematoma
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Cardiotoxicity
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Anal fissure haemorrhage
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Injection site mass
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
General disorders
Sensation of foreign body
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Anal fungal infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Genital candidiasis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Coronavirus test positive
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Occult blood positive
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Thyroxine increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
Weight increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Investigations
White blood cell count increased
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
100.0%
1/1 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Reproductive system and breast disorders
Genital lesion
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
20.0%
1/5 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Reproductive system and breast disorders
Perineal pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Reproductive system and breast disorders
Premature menopause
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 4 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Itching scar
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Palmar erythema
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Umbilical discharge
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Cardiac dysfunction
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Cardiac disorders
Systolic dysfunction
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/31 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
5.0%
1/20 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 3 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/2 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/5 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/7 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
3.2%
1/31 • Number of events 1 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/11 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
0.00%
0/20 • From the date of first dose of study drug up to 30 days after the last dose (up to approximately 7 years)
Safety analysis set included all participants who received any study drug and had at least one post-baseline safety evaluation. The difference in the numbers of deaths in the Participant Flow module versus the Adverse Events module is because the deaths presented in the Participant Flow module are based from the Full Analysis Set while the deaths presented in the Adverse Events module are based from the Safety Population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER